Application 211843

Type: NDA
Sponsor: MISSION PHARMACAL CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THIOLA EC	TIOPRONIN	TABLET, DELAYED RELEASE;ORAL	100MG	Yes	No
002	THIOLA EC	TIOPRONIN	TABLET, DELAYED RELEASE;ORAL	300MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N211843-001	THIOLA EC	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28
N211843-002	THIOLA EC	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N211843-001	AB
N211843-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211843-001	11458104	2038-11-14	U-3441		2022-10-06
N211843-002	11458104	2038-11-14	U-3441		2022-10-06

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211843-001	ODE*	2026-06-28
N211843-002	ODE*	2026-06-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N211843-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N211843-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N211843-001	11458104	2038-11-14	U-3441		2022-10-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N211843-002	11458104	2038-11-14	U-3441		2022-10-06	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N211843-001	ODE*	2026-06-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N211843-002	ODE*	2026-06-28	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Thiola EC	TIOPRONIN	Mission Pharmacal Company	20298a52-a194-a161-8632-d84b6f26e23c	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211843 application number: NDA211843 ndc (product): 0178-0902 ndc (product): 0178-0901
Tiopronin	TIOPRONIN	BioComp Pharma, Inc.	1f2eb1d6-faa6-e352-e063-6294a90a7fb5	2025-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211843 application number: NDA211843

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0178-0901	Thiola EC	tiopronin	Mission Pharmacal Company	NDA	Current
0178-0901	Thiola EC	tiopronin	Mission Pharmacal Company	NDA	Current
0178-0902	Thiola EC	tiopronin	Mission Pharmacal Company	NDA	Current
0178-0902	Thiola EC	tiopronin	Mission Pharmacal Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66731	SUPPL	2021-03-10
66677	SUPPL	2021-03-09
61493	ORIG	2020-01-02
59222	ORIG	2019-07-02
59200	ORIG	2019-07-01